Practical and methodological challenges when conducting a cluster randomized trial: Examples and recommendations - 09/02/24

Doi : 10.1016/j.jeph.2024.202199

Agnès Caille ^a,^b,^⁎ , Laurent Billot ^c, Jessica Kasza ^d
^a Université de Tours, Université de Nantes, INSERM, SPHERE U1246, Tours, France
^b INSERM CIC 1415, CHRU de Tours, Tours, France
^c The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia
^d School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia

^⁎Corresponding author.

Abstract

The use of cluster randomized trial design to answer research questions is increasing. This design and associated variants such as the cluster randomized crossover and stepped wedge are useful to assess complex interventions in a pragmatic way but when adopting such designs, one may face specific implementation challenges. This article summarizes common challenges faced when conducting cluster randomized trials, cluster randomized crossover trials, and stepped wedge trials, and provides recommendations.

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Keywords : Cluster randomized trial, Stepped-wedge, Cross-over, Challenges, Implementation, Design, Methodological recommendations

Plan

Introduction

Methods

General challenges when conducting a CRT

Challenge 1: A cluster drops out

Challenge 2: Two clusters merge during the trial

Challenge 3: Splitting of clusters

Challenge 4: A participant changes cluster or is included several times

Challenge 5: There is an imbalance in the number of participants recruited by cluster or by cluster-period

Challenge 6: There is an imbalance in the characteristics of participants recruited by cluster or by cluster-period

Specific challenges for CRXO

Challenge 1: Adequate planning of period duration

Challenge 2: Avoiding carry over effect

Specific challenges for SW

Challenge 1: Clusters are not all available to start at same date

Challenge 2: Changes in the control condition/usual practice occur

Challenge 3: Experimental intervention is not implemented according to the schedule

Challenge 4: Effect of experimental intervention changes over time

Conclusion

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Vol 72 - N° 1

Article 202199- février 2024 Retour au numéro

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Practical and methodological challenges when conducting a cluster randomized trial: Examples and recommendations - 09/02/24

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